Job Description
CRA SSU - Experience in monitoring and regulatory - Sponsor dedicated - Colombia Home Based
Job Description: Senior Clinical Research Associate responsible for site qualification, monitoring, and site management for clinical trials conducted in Colombia on a home-based, sponsor‑dedicated arrangement.
Job Responsibilities
- Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site‑specific actions; immediately communicate/escalate serious issues to the project team and with guidance develop action plans. Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.